Biocides Regulation
Biocides Regulation
Biocidal products are used to control harmful or unwanted organisms through chemical or biological action. They include disinfectants, preservatives, pest control products, antifouling products and a wide range of other specialist applications.
Because biocides are specifically intended to control harmful organisms, their active substances and products are subject to regulatory controls. Organisations manufacturing, supplying or supporting biocidal active substances and products may therefore need to consider active substance approval, renewal, product authorisation, data and evidence requirements, substitution and the implications of regulatory decisions for continued market access.
RPA supports companies, consortia and other organisations working with biocidal active substances and products. We combine regulatory, scientific and economic analysis to help clients understand regulatory requirements, develop robust evidence and make informed decisions about approval, renewal and market access.
What are biocides?
A biocidal product is a product intended to control harmful or unwanted organisms through a chemical or biological action.
Under the EU Biocidal Products Regulation, biocidal products are divided into 22 product types across four broad groups: disinfectants, preservatives, pest control products and other biocidal products.
These categories cover applications ranging from human and veterinary hygiene and material preservation to insecticides, rodenticides and antifouling products.
Whether a product falls within biocides legislation depends on its composition, intended purpose and mode of action. Some products can instead or additionally fall within other regulatory regimes, so establishing the applicable legislation is an important starting point.
How are biocides regulated?
Biocides regulation operates at two related levels: active substances and biocidal products.
Active substances are assessed and approved for specified product types. Biocidal products containing those substances are then generally required to obtain an appropriate product authorisation before they can be made available on the market.
The regulatory status of an active substance can therefore have direct consequences for products further down the supply chain. Changes to an approval, a renewal decision or the identification of regulatory concerns can affect the evidence required, the conditions of use and, potentially, the future availability of products that rely on that substance.
For businesses, biocides regulation is consequently not only a question of individual product compliance. It can also affect regulatory investment, product portfolios, supply chains and longer-term market access.
EU Biocidal Products Regulation
Biocidal products in the European Union are regulated principally under Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products, commonly referred to as the Biocidal Products Regulation or EU BPR.
Under EU BPR, active substances normally need to be approved for the relevant product type before an authorisation can be granted for a biocidal product containing them.
Active substances are evaluated by an evaluating competent authority, followed by peer review through ECHA’s Biocidal Products Committee. The European Commission takes the subsequent approval decision.
Active substance approvals are time limited and may be renewed.
Biocidal products must then meet the applicable requirements for authorisation. Depending on the circumstances, routes under EU BPR include national authorisation, mutual recognition and Union authorisation.
Read the legislation:
Biocides regulation in Great Britain and Northern Ireland
Biocidal products supplied in England, Scotland and Wales are regulated under the GB Biocidal Products Regulation (GB BPR).
The Health and Safety Executive (HSE) acts as the competent authority under GB BPR.
As under EU BPR, an active substance must normally be approved for the relevant product type before a product containing it can be authorised under GB BPR. HSE maintains information on active substance status, approvals and product authorisations.
The EU BPR applies in Northern Ireland. Organisations operating across Great Britain, Northern Ireland and EU markets therefore need to establish the regulatory position for each relevant market rather than assuming that a substance or product has the same regulatory status in all jurisdictions.
Transitional arrangements can also remain relevant to some products, including products regulated under the Control of Pesticides Regulations (COPR) while their active substances continue through the applicable review programme.
Further information on the GB and Northern Ireland systems is available from HSE’s biocides guidance.
Active substance approval and renewal
Active substance approval is central to the biocides regulatory system.
Approval relates to a particular active substance and product type and is granted for a defined period. Organisations wishing to continue supporting an active substance beyond its approval period may therefore need to prepare for renewal well in advance of expiry.
Renewal can involve substantial scientific and regulatory evidence. Depending on the substance and issues identified during assessment, organisations may also need to consider the implications of hazard classifications, exclusion or substitution criteria, available alternatives and the consequences associated with different regulatory outcomes.
These questions can require more than the preparation of a regulatory dossier. They may involve decisions about evidence generation, regulatory strategy, the importance of particular uses and the commercial and socio-economic consequences of continued approval or its absence.
RPA supports active substance approval and renewal work through regulatory analysis, evidence assessment, scientific and economic analysis and regulatory strategy.
Biocidal product authorisation and market access
Approval of an active substance does not automatically authorise products containing it.
Biocidal products must meet the applicable requirements for product authorisation before being placed on the relevant market, subject to the specific regulatory and transitional arrangements that apply.
The appropriate route depends on the product, its active substances, intended uses and the markets in which it will be supplied.
For companies operating across multiple markets or managing portfolios of biocidal products, understanding the relationship between active substance status and product authorisation can be important for planning future regulatory investment and maintaining market access.
Exclusion criteria, candidates for substitution and comparative assessment
The BPR contains provisions intended to address active substances with particular hazardous properties.
Certain substances may meet exclusion criteria, meaning that they should in principle not be approved unless specified derogation conditions are met.
The legislation also identifies candidates for substitution. Where an active substance meets the relevant criteria, products containing that substance are subject to comparative assessment when relevant product authorisation or renewal decisions are made.
Comparative assessment considers whether another authorised biocidal product or a non-chemical control or prevention method is available that presents a significantly lower overall risk, is sufficiently effective and does not present other significant economic or practical disadvantages.
The assessment of alternatives can therefore involve scientific, technical, practical and economic evidence rather than simply identifying whether another substance or technology exists.
An analysis of alternatives (AoA) can provide a structured assessment of potential alternatives to a biocidal active substance.
Depending on the regulatory context, this can involve considering the function performed by the substance, the availability and effectiveness of alternatives, human health and environmental considerations, technical feasibility and the practical and economic consequences of substitution.
ECHA has developed specific guidance to support applicants and authorities undertaking analysis of alternatives for biocidal active substances.
ECHA guidance:
RPA undertakes analysis of alternatives and can bring together regulatory, scientific and economic evidence to assess the feasibility and implications of potential substitution.
Socio-economic analysis for biocides
Regulatory decisions concerning biocidal active substances can have consequences for manufacturers, users, supply chains and the wider economy.
Socio-economic analysis (SEA) provides a framework for assessing those consequences where they are relevant to the regulatory question.
This can include consideration of the benefits provided by an active substance or particular uses, the costs and impacts associated with alternative regulatory outcomes, the availability and feasibility of alternatives, impacts on affected sectors and supply chains, and consequences for users and wider society.
The appropriate analysis depends on the decision being considered and the evidence available. RPA combines economic analysis with scientific and regulatory understanding to develop evidence that is relevant to the regulatory process rather than treating SEA as a separate modelling exercise.
How RPA supports organisations working with biocides
Biocides regulation can bring together questions of regulatory interpretation, scientific evidence, economic impacts and commercial strategy.
RPA is an independent consultancy with experience in chemicals and product regulation and in the development and assessment of regulatory evidence.
Our biocides work can include:
- active substance approval and renewal support;
- regulatory strategy and evidence assessment;
- socio-economic analysis;
- analysis of alternatives;
- scientific, economic and regulatory evidence reviews;
- assessment of market-access and portfolio implications; and
- stakeholder and industry evidence development.
Our approach depends on the regulatory question. We work with clients to establish what evidence is required, understand where uncertainties or evidence gaps remain and develop analysis that can support regulatory and commercial decision-making.
Further biocides guidance
For authoritative regulatory information, organisations should also refer to the relevant regulator and legislation.
European Chemicals Agency (ECHA) — Biocidal Products Regulation